Study Leader

ALTEN Canada; Cambridge; On-site; CAD 41,328 - 48,216; Full time

Job summary

ALTEN Canada seeks an experienced study leader to oversee a 7-week POD study of pre-filled syringes in a controlled pharmaceutical environment. You will guide operators in visual inspection, ensure GDP compliance, and maintain data integrity across the study.

Responsibilities include monitoring activities for consistency, performing quality checks, documenting observations, and coordinating with QA and management to keep the study on time and meets regulatory requirements.

Qualifications

• Experience in Pharma with GDP familiarity.
• Has passed a visual acuity test within 24 months.
• Able to work independently and lead operators.

Responsibilities

• Lead and support operators in visual inspection of pre-filled syringes.
• Monitor inspection activities for consistency and accuracy.
• Ensure GDP compliance and proper documentation of all work.
• Perform quality checks by reviewing samples and validating operator findings.
• Troubleshoot issues and escalate deviations during the study.
• Document observations and study progress for reporting.
• Coordinate with QA and management for updates and study execution.
• Manage workflow across shifts to maintain on-time progress.

Skills

Independent work

Pharma industry

Visual acuity testing

Communication skills

Problem solving

Tools

MS Office

Job description

In just three decades, ALTEN has become a global leader in Research & Development, Engineering, IT Services, Life Sciences, and Network Services. With a presence in more than 30 countries and a team of over 60,000 employees, we are trusted by industry leaders worldwide to deliver pioneering solutions and drive technical excellence.

ALTEN CANADA, a proud subsidiary of ALTEN headquartered in France, is dedicated to serving the Canadian market. With offices in Montreal and Toronto, we combine global expertise with local insight to accelerate innovation across Canada.

At ALTEN CANADA, our consultants thrive on solving complex, highly technical challenges across diverse industries. From Life Sciences to Energy, Automation to Manufacturing, Aviation, Defense. Automotive, Rail and Transportation to Information Systems and Telecommunications, our unwavering commitment to excellence shaping the future of technology and industry.

Context of the project: This project is a 7-week POD study focused on pre-filled syringes (PFS), conducted in a controlled pharmaceutical manufacturing environment. The study involves visual inspection activities to assess defect detection, operator performance, and overall process consistency under defined conditions. Operators will be performing inspection at light stations, while Study Leaders oversee execution to ensure adherence to SOPs, data integrity (GDP), and consistent application of inspection criteria.

Day-to-day tasks

Key Responsibilities:

• Lead and support operators performing visual inspection of pre-filled syringes, ensuring they understand what to look for and follow the study procedures correctly.
• Monitor inspection activities to confirm consistency and accuracy, stepping in when guidance or clarification is needed.
• Ensure compliance with protocols and regulations, including Good Documentation Practices (GDP), so all work is properly recorded.
• Perform quality checks by reviewing samples yourself to validate operator findings and maintain study integrity.
• Troubleshoot and elevate issues when unexpected situations or deviations occur during the study.
• Maintain accurate documentation of observations, results, and study progress for reporting and regulatory purposes.
• Communicate effectively with other teams, including QA and management, to provide updates and ensure smooth study execution.
• Manage workflow across shifts to maintain continuous, on-time study progress and consistent coverage.

Candidate requirements

Must-haves:

• Can work independently and provide guidance/directions to operators on the study
• Experience working in Pharma (familiar with GDP)
• Passed visual acuity testing within the past 24 months. The current standards for visual acuity testing are corrected or uncorrected near acuity in at least one eye, equal to or exceeding 20/20 reduced Snellen

Nice to have:

• Experience with POD studies
• Experience working with the syringe formats
• Tools / software / methodology / certification: MS Office
• Soft skills: Strong organizational and communication skills. Ability to work autonomously; proactive problem-solving and decision-making
• Seniority level: intermediate

Why Join Us?

ALTEN Canada fosters a dynamic, collaborative work environment where every team member is empowered to reach their full potential. We are deeply committed to investing in our people by offering meaningful experiences and supporting continuous learning, growth, and career development.

As part of our dedication to employee well-being, we provide a competitive and comprehensive benefits package that includes:

• Collective insurance and group retirement savings plans
• 4 weeks of vacation starting from year one
• Corporate discounts and team-building activities

At ALTEN Canada, your skills are celebrated, your ambitions supported, and your growth continuously nurtured. Join us and discover the difference of working with a company that values innovation, collaboration, and excellence, where endless possibilities await.

ALTEN CANADA is committed to promoting diversity, equity, and inclusion. We strive to provide a work environment where every individual feels welcomed, valued, and respected, allowing them to thrive to their full potential. This includes our dedication to offer accessibility measures to those who require them. Should you require any accommodation during our recruitment process, please reach out to us.

Alten uses artificial intelligence tools to support certain administrative aspects of the recruitment process, such as interview note-taking and résumé formatting. These tools do not make hiring decisions. Candidate consent is always obtained prior to use.

In accordance with our compensation practices, ALTEN is providing the salary range associated with this opportunity. Final compensation will be determined after considering several factors, including professional experience, skill set, educational background, certifications, and geographic market conditions. The current target salary range for this role is $30 - $35 per hour.

This job posting corresponds to an active and immediate vacancy currently open with one of Alten's clients.